MAUDE Adverse Event Report: PERFUSION SYSTEMS AFFINITY NT BALANCE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	511B
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
(pli 10, 20): medtronic received information that during use of a affinity nt cvr (cardiotomy venous reservoir), and a pixie hollow fiber oxygenator it was reported that the affinity reservoir had a crack at the connection point, resulting in bubble formation and the pixie oxy had a leakage between the heat exchanger and the main reservoir.See attached video.Use of device was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Correction b5: medtronic received information that during use of a affinity nt oxygenator, it was reported that the device had a crack at the connection point, resulting in bubble formation and a leaking fiber.See attached video.The device was replaced to complete the case.There was no adverse patient effect associated with this event.Correction d1: brand name updated correction d4: model and catalog number information updated.Correction h6: updated the annex a code and annex e code medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction b5: both of the devices were replaced to complete the case medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: AFFINITY NT BALANCE
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24982377
• Report Number: 2184009-2026-00495
• Device Sequence Number: 9480767
• Product Code: DTZ
• UDI-Device Identifier: 00763000187842
• UDI-Public: (01)00763000187842(17)270714(10)231772685
• Combination Product (Y/N): N
• Initial Reporter Country: KG
• PMA/510(K) Number: K241352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 511B
• Device Catalogue Number: 511B
• Device Lot Number: 231772685
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 04/30/2026; Not provided; 07/06/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/07/2026; 05/12/2026; 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown